Prediction of Propofol Effect Compartment Concentrations

NCT ID: NCT05940142

Last Updated: 2023-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-05-31

Brief Summary

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The goal of this observational study is to learn about the prediction of the effect of Propofol by means of EEGs. The main questions it aims to answer are:

* Develop models that can reliably predict the effect of Propofol
* Select the most well suited model for clinical practice
* Compare this model to already existing models (e.g. Schnider-model)

Participants will asked to allow us to collect and use the EEG data recorded during the operations.

Detailed Description

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Conditions

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Analysis of Anaesthesia Depth

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Age of 18 or older at the time of the signature of the informed consent
* Signed informed consents
* Planned TIVA with Propofol

Exclusion Criteria

* Use of extracorporal circulation (e.g., HLM, ECMO)
* Admission to an ICU/IMCU before the operation or planned admission to an ICU/IMCU after the operation
* Administration of Propofol seven days prior to the planned operation
* Missing informed consent
* All contraindications against TIVA (e.g., allergy against Propofol or soy)
* All operations where BIS monitoring cannot be used (e.g., skin lesions on the front)
* Patients for which the administration of Propofol could be potentially harmfull (e.g., severe heart failure with the risk of drop of blood pressure)
* Neurosurgical operations
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karl Landsteiner University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Klinische Abteilung für Anästhesie und Intensivmedizin

Krems, Lower Austria, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Robert Fritze, MD

Role: CONTACT

++43/2732/9004-14055

Facility Contacts

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Robert Fritze, MD

Role: primary

++43/2732/9004-14055

Other Identifiers

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SF44

Identifier Type: -

Identifier Source: org_study_id

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